Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
220
Countries
1
Sites
6
Obesity
To confirm superiority of once-weekly semaglutide s.c. 2.4 mg versus once-weekly semaglutide s.c. placebo, both as an adjunct to a 52-week blended face-to-face (F2F) and electronic behavioral therapy (eBT) program in treatment-seeking adolescents (12 to <18 years) with obesity on percentage reduction in body weight (%…
Key facts
- Sponsor
- Vestfold Hospital Trust
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Trial duration
- 28 Feb 2025 → ongoing
- Decision date (initial)
- 2023-11-16
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Klinisk behandlingsforskning · Vestfold Hospital Trust · Simon Fougner Hartmanns Familiefond
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Safety, Efficacy
To confirm superiority of once-weekly semaglutide s.c. 2.4 mg versus once-weekly semaglutide s.c. placebo, both as an adjunct to a 52-week blended face-to-face (F2F) and electronic behavioral therapy (eBT) program in treatment-seeking adolescents (12 to <18 years) with obesity on percentage reduction in body weight (% BMI change) [after completion of an initial 8-week blended F2F and electronic LED (eLED)].
Secondary objectives 1
- Main secondary objectives: 1. to compare the safety and tolerability of semaglutide s.c. 2.4 mg once-weekly versus semaglutide s.c. placebo as an adjunct to eBT (week 8-60). 2. to compare the effect of semaglutide s.c. 2.4 mg once-weekly versus semaglutide placebo as an adjunct to eBT on a number of measures including body composition, cardiometabolic risk factors and biomarkers, physical activity, sleep, and various patient reported outcomes. 3. to assess the feasibility, safety, and preliminary effectiveness of an 8-week eLED intervention (week 0-7). 4. to assess the feasibility of a 52-week eBT intervention for weight loss maintenance (week 8-60).
Conditions and MedDRA coding
Obesity
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | eHealth Based treatment of AdolescenT obesiTy with Low energy diet and sEmaglutide (eBATTLE Obesity) 52-week behavioral therapy with once-weekly semaglutide or placebo
|
Randomised Controlled | Double | [{"id":96281,"code":5,"name":"Carer"},{"id":96283,"code":3,"name":"Monitor"},{"id":96284,"code":2,"name":"Investigator"},{"id":96282,"code":1,"name":"Subject"},{"id":96280,"code":4,"name":"Analyst"}] |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Participants are eligible to be included in the study only if all of the following criteria apply: 1. Informed consent of parent(s) or legally authorized representative (LAR) of subject and assent of adolescent, as appropriate obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial 2. The trial participant must be above or equal to 12 years and below 18 years of age at the time of signing the informed consent. 3. Treatment seeking male and female adolescent patients with obesity (BMI ≥ IOTF 35 kg/m2) OR BMI ≥ IOTF 30 kg/m2 with at least one weight related comorbidity, risk factor or complication, as considered by the treating physician (44). 4. History of at least one self-reported unsuccessful dietary effort to lose body weight 5. Capable of giving signed informed consent as described in Appendix 3 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the study protocol.
Exclusion criteria 1
- Participants are excluded from the study if any of the following criteria apply: 1. Prepubertal patients (Tanner stage 1), self-assessed, see 8.2.1, table 1. 2. History of diabetes mellitus (type 1 or type 2) as judged by the investigator 3. Intellectual disability as judged by the investigator 4. Sub-optimal level of spoken Norwegian as judged by the investigator
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Percentage change in BMI (Time frame: From week 8 to week 60)
Secondary endpoints 1
- The main secondary endpoints include the number and severity of adverse events, physical activity, sleep, psychiatric symptoms, eating disorder symptoms, and health-related quality of life. In addition, changes in fat mass, fat-free mass, blood glucose, blood lipids, blood pressure, and other cardiometabolic risk factors will be compared between the treatment groups.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Semaglutide B 3.0 mg/mL PDS290 or semaglutide placebo
PRD10981815 · Product
- Active substance
- Semaglutide
- Substance synonyms
- NNC0113-0217
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INJECTABLE SOLUTION
- Max daily dose
- 0.34 mg milligram(s)
- Max total dose
- 2.4 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- ORG45751
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 1
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Vestfold Hospital Trust
- Sponsor organisation
- Vestfold Hospital Trust
- Address
- P. O. Box 2168
- City
- Tonsberg
- Postcode
- 3103
- Country
- Norway
Scientific contact point
- Organisation
- Vestfold Hospital Trust
- Contact name
- Hormon, overvekt og ernæringsavdelingen - forskning
Public contact point
- Organisation
- Vestfold Hospital Trust
- Contact name
- Hormon, overvekt og ernæringsavdelingen - forskning
Locations
1 EU/EEA country · 6 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Norway | Ongoing, recruiting | 220 | 6 |
| Rest of world | — | 0 | — |
Investigational sites
Vestfold Hospital Trust
Klinikk medisin, P. O. Box 2168, 3103, Tonsberg
Oslo University Hospital HF
Sosialpediatrisk seksjon, Taarnbygget, Kirkeveien 166, Oslo
Helse Bergen HF
Barne og ungdomsklinikken, Jonas Lies Vei 65, 5021, Bergen
Finnmarkssykehuset HF
Barnepoliklinikken, Sykehusveien 35, 9601, Hammerfest
St. Olavs Hospital HF
Kirurgisk klinikk, Prinsesse Kristinas G. 3, 7030, Trondheim
Nordlandssykehuset HF
Barnepoliklinikken, Parkveien 95, 8005, Bodo
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Norway | 2025-02-28 | 2025-02-28 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Serious breaches 2 · Art. 52 CTR
Serious breach SB-121353
- Sponsor became aware
- 2026-02-23
- Date of breach
- 2025-05-07
- Submission date
- 2026-02-27
- Member states concerned
- Norway
- Categories
- Protocol, Regulation
- Areas impacted
- Data reliability or robustness, Subject safety
- Benefit-risk balance changed
- No
- Description
- The participant was dispensed a wrong kit number / Dispensing Unit Number (DUN) at randomisation (week 8, May 7, 2025) which might have resulted in a wrong IMP (placebo or semaglutide) the first 22 weeks of the study. The participant has received the correct IMP from week 30 (second drug dispensing visit) until week 51 (current week),and will be offered to continue with the drug until week 60 (EOT).
- Sponsor actions
- Corrective: 1. Local PI (Site 2) have arranged a face-to-face meeting with participant and parents and informed about the breach and potential consequences during the first week after becoming aware of the previous breach.
2. Local PI has also invited the family to a new meeting to continue the communication on how to proceed. If the participant/parents want to continue participating in the study taking the correct IMP (since week 30), the participant will continue taking the correct IMP another 9 weeks (until week 60) without unblinding.
3. Further progress will be discussed with the participant/parents until week 64 (end of study).
4. The participant’s data will be flagged for further discussion on how to be used in the analyses with the study statisticians before the final study report.
5. The incident will be documented in the patient record, eCRF and the eTMF
Preventive:
1. The pharmacy argues that their standard operating procedures (SOPs) are appropriate, and that they will not change these procedures despite this incident human error.
2. Although the cause of this breach was related to drug dispensing at the pharmacy, the research staff in eBATLE (all sites) will be reminded about our existing SOP 8 regarding IMPrandomisation, allocation, and drug Dispensing Unit Number. This information will be delivered and discussed at the next ordinary research staff meeting and in the first biweekly meeting with the PIs.
| Organisation | City | Country | Type |
|---|---|---|---|
| Oslo University Hospital HF | Oslo | Norway | Clinical facility BE/BA |
Serious breach SB-124459
- Sponsor became aware
- 2026-03-17
- Date of breach
- 2026-03-17
- Submission date
- 2026-03-20
- Member states concerned
- Norway
- Categories
- Protocol
- Areas impacted
- Data reliability or robustness
- Benefit-risk balance changed
- No
- Description
- The participant has undergone medical treatment and rehabilitation after hospitalisation (previous SAE probably not related to treatment) after Week 6 in the low-energy-diet phase of the study (Nov 17, 2025). Visit Week 7 was postponed until he had fully recovered and his nutrition status again allowed low energy diet. He has gradually changed changed his diet the last weeks and should be back to almost similar condition as before he became ill; week 6 according to protocol. His body weight is slightly above that registered at Nov 14 (109 kg), recently 112 kg, and he reports feeling fine and is highly motivated to continue participating in the study.
The participant’s data will be flagged for further discussion on how to be used in the analyses with the study statisticians before the final study report. - Sponsor actions
- Not applicable (acute illness not related to study with long rehabilitation period)
| Organisation | City | Country | Type |
|---|---|---|---|
| Finnmarkssykehuset HF | Hammerfest | Norway | Clinical facility BE/BA |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 9 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2023-506289-29-00 | 1.3 |
| Protocol (for publication) | D4_intervjuskjema c-ssrs norsk | 1 |
| Protocol (for publication) | D4_Patients facing document_DFU__NO | 1 |
| Protocol (for publication) | D4_sprreskjema EQ-5D-Y Norsk | 1 |
| Protocol (for publication) | D4_sprreskjema IWQOL-Kids Norsk | 1 |
| Protocol (for publication) | D4_sprreskjema PHQ-9 pa norsk | 1 |
| Protocol (for publication) | D4_sprreskjema YouthEDEnorsk | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | wegovy-epar-product-information_no | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_NO 2023-506289-29-00 | 1 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-08-08 | Norway | Acceptable 2023-11-15
|
2023-11-16 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-11-23 | Norway | Acceptable 2023-12-13
|
2023-12-14 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-11-21 | Norway | Acceptable 2025-01-23
|
2025-01-24 |